Luxembourg medical device registration timeline
Source-linked clocksDirection de la santé, Ministry of Health and Social Security (Direction de la santé) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — EU MDR classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I(Self-declaration (no notified body)) MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock | 0 days | 6-9 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesLuxembourg Medical Device Registration Process
Step-by-step Direction de la santé registration process. Total estimated timeline: 6-9 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by Direction de la santé. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to Direction de la santé including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksDirection de la santé reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. Direction de la santé may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, Direction de la santé issues Luxembourg market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- National Class I and IVD registration with the Direction de la santé (meddevices@ms.etat.lu) applies only where the manufacturer or its authorised representative is established in Luxembourg; higher classes are registered directly in Eudamed once actor registration is validated
- Economic operators established in Luxembourg register through the Eudamed actor registration module and each request must be validated by the competent authority; no processing clock is published
- Labelling and instructions must be in French or German for active implantable devices, and in French, German or Luxembourgish for other devices and IVDs
- Clinical investigations are filed with the ministry on the MDCG 2021-08 Annex I form pending Eudamed, under the MDR Art. 70 clocks; the report is due within one year of completion or three months after early termination
- Art. 59 derogation requests and vigilance reports go to the Direction de la santé rather than through any national pre-market approval
Reviewed 2026-08-29. End-to-end totals remain planning estimates.